The Efficacy of Stellate Ganglion Block as PTSD Therapy: A Pilot Study
试验速览
- 阶段
- 2 期
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Difference in CAPS score activity
研究概览
简要总结
RATIONALE: A stellate ganglion nerve block may help relieve symptoms of post-traumatic stress disorder (PTSD).
PURPOSE: This pilot clinical trial is studying the efficacy of a stellate ganglion nerve block in veterans to reduce the symptoms of PTSD in relatively long-standing (Vietnam era) induced or relatively recently induced PTSD (from deployment in Afghanistan or Iraq as part of Operations Enduring Freedom (OEF), Iraqi Freedom (OIF), and New Dawn (OND).
详细描述
Objectives:
- Stellate ganglion blocks will be performed in a small sample (n = 12) of the local patient population that suffers from PTSD in order to replicate other preliminary findings.
- The parameters that lead to a successful treatment response will be evaluated by comparing and contrasting the results obtained in younger (n=6) OEF/OIF generation veterans versus older (n=6) Vietnam generation veterans.
- The individual difference variables that might lead to successful treatment responses will be studied by obtaining correlative measures of psychological and psychometric data and responses to standardized tests.
Research Design:
This is an open label unblinded clinical pilot case series study to determine the efficacy of stellate ganglion blockade for relief of PTSD symptoms in the Long Beach VA healthcare population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Include significant PTSD symptoms with severe hyper-arousal symptoms.
- •Clinician Administered PTSD Scales (CAPS) score, with a total score ≥ 50 needed for enrollment.
- •Hyper-arousal severity identified by a high score on the CAPS D scale and a ≥ 10 beat per minute increase in heart rate during the subject's verbal recollection of a standardized version of their traumatic exposure.
排除标准
- •Include psychiatric and medical conditions that would make patients poor candidates for an outpatient procedure.
- •Subjects must be able to be cooperative for the procedure and free of significant medical problems that would pose a constant threat to life.
结局指标
主要结局
Difference in CAPS score activity
时间窗: Baseline and weeks 1, 4, 12 and 26
次要结局
- Biophysical responses(Baseline and weeks 1, 4, 12 and 26)
- Depression scale(Baseline and weeks 1, 4, 12 and 26)
- Anxiety scale(Baseline and weeks 1, 4, 12 and 26)
- Quality of life scale(Baseline and weeks 1, 4, 12 and 26)